Tag Archives: Medical Devices

FDA 510k Consultants in UK For Medical Device

Manufacturers of class II and a few class I class III medical devices must receive FDA 510k clearance before their product can be legally sold in the United States. Role of Biocompatibility Testing in FDA 510k Clearance Biocompatibility is defined as the ability of the material or a medical device to be compatible with the living tissue. …

FDA 510k Submission Services in UK For Different Type of Medical Devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. Any medical device approved by the FDA Center for Devices and Radiological Health is classified…